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Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis

This study has been completed.
Sponsor:
Information provided by:
Urigen
ClinicalTrials.gov Identifier:
NCT00517868
First received: August 15, 2007
Last updated: April 7, 2008
Last verified: April 2008
History of Changes
  Purpose

A double-blind, placebo-controlled study to evaluate changes in pain, urgency and urinary frequency following administration of URG101 compared to placebo.


Condition Intervention Phase
Painful Bladder Syndrome
Interstitial Cystitis
 Drug: URG101
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: URG101 Pharmacodynamic and Safety Study: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Cross-Over Study to Investigate the Pharmacodynamic Profile of URG101 in Subjects With Pelvic Pain of Bladder Origin.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Urigen:

Primary Outcome Measures:
  • Average % Change in Daytime Bladder Pain Score [ Time Frame: T0 - 12hr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PORIS - Question 3 - ≥50% Overall Improvement [ Time Frame: T 0.5hr ] [ Designated as safety issue: No ]
  • Average % Change in Total Symptom Score (pain + urge) [ Time Frame: T0 - 12hr ] [ Designated as safety issue: No ]
  • Average % Change in Daytime Urinary Urgency Score [ Time Frame: T0-12hr ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: August 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Crossover
Placebo Treatment on Visit 1 followed by URG101 Treatment on Visit 2
 Drug: URG101
Bladder instillation of URG101 or Placebo in random order on treatment 1 and treatment 2 followed by an open-label URG101 on treatment 3 within the same week.
Drug: Placebo
Liquid formulation without active URG101 drug components
Crossover 2
URG101 Treatment on Visit 1 followed by Placebo Treatment on Visit 2
 Drug: URG101
Bladder instillation of URG101 or Placebo in random order on treatment 1 and treatment 2 followed by an open-label URG101 on treatment 3 within the same week.
Drug: Placebo
Liquid formulation without active URG101 drug components

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male and female subjects >= 18 years of age
  • moderate to severe symptoms of PBS/IC
  • minimum pain/urgency/frequency scores
  • female subjects on hormone therapy must be on stable dose for >= 3 months

Exclusion Criteria:

  • positive pregnancy test or pregnant or lactating
  • narcotics or medical marijuana within 3 months
  • use of any investigational drug or device within 30 days
  • bacterial cystitis within 30 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00517868

Locations
United States, California
Citrus Valley Medical Research
Glendora, California, United States, 91741
SD Uro-Research
San Diego, California, United States, 92103
University of California, San Diego
San Diego, California, United States, 92103
Scripps Clinic Medical Group
San Diego, California, United States, 92130
United States, Georgia
Georgia Urology
Cartersville, Georgia, United States, 30120
United States, Texas
Urology San Antonio Research, P.A.
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Urigen
Investigators
Principal Investigator: Jeff Proctor, M.D. Georgia Urology
  More Information

No publications provided

Responsible Party: Dennis Giesing, PhD, Chief Scientific Officer, Urigen Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00517868     History of Changes
Other Study ID Numbers: URG101-104
Study First Received: August 15, 2007
Last Updated: April 7, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Urigen:
bladder
pain
urgency
frequency

Additional relevant MeSH terms:
Cystitis
Pain
Cystitis, Interstitial
Urinary Bladder Diseases
 Urologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013